Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ARIPIPRAZOLE
MEDISPEC (M) SDN.BHD
ARIPIPRAZOLE
30tablet Tablets; 30tablet Tablets
UNISON LABORATORIES CO.LTD
APALIFE 10MG TABLET APALIFE 15MG TABLET Aripiprazole (10mg, 15mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _Apalife_ is used for 2. How _Apalife_ works 3. Before you use _Apalife_ 4. How to use _Apalife_ 5. While you are using it 6. Side effects 7. Storage and Disposal _Apalife_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _APALIFE_ IS USED FOR Treatment of acute episodes of schizophrenia and for maintenance of clinical improvement during continuation therapy. Aripiprazole is indicated for the treatment of acute manic episodes associated with Bipolar I Disorder. HOW _APALIFE_ WORKS _Apalife _ (Aripiprazole) is an antipsychotic medication. It works by changing the actions of chemicals in the brain. BEFORE YOU USE _APALIFE_ - _When you must not use it _ If you are allergic to Aripiprazole or any of the other ingredients of _Apalife_ . _ _ _ _ _Pregnancy and lactation _ Do not take _Apalife_ if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take _Apalife_ if you are breast- feeding. Ask your doctor or pharmacist for advice before taking any medicine. _ _ - _Before you start to use it _ Talk to your doctor before taking _Apalife _ if you suffer from: _ _ High blood sugar or family history of diabetes Seizures Involuntary, irregular muscle movements, especially in the face. Heart disease, family history of heart disease, stroke or “mini” stroke, abnormal blood pressure You have ADHD (Attention Deficit Hyperactivity Disorder) You are under 18 years old. You have lactose intolerance. You are an elderly suffering from dementia (loss of memory) You have a history of excessive gambling or other unusual urges (eg. increased sexual urges, binge or compulsive eating, and compulsive shopping) - _Taking other medicines _ Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health f Baca dokumen lengkapnya
APALIFE TABLET ANTIPSYCHOTIC Each film coated tablet contains: ARIPIPRAZOLE 10 MG ARIPIPRAZOLE 15 MG ♦ PRODUCT DESCRIPTION: _10 MG: _ Pink, modified rectangle, biconvex, film coated tablet with engraved 10 on one side and plain on the other _15 MG: _ Yellow, round, biconvex, film coated tablet with engraved 15 on one side and plain on the other ♦ MECHANISM OF ACTION: _PHARMACOLOGY _ It has been proposed that Aripiprazole's efficacy in schizophrenia and Bipolar I Disorder is mediated through a combination of partial agonism at dopamine D2 and serotonin 5HT1a receptors and antagonism of serotonin 5HT2a receptors. Aripiprazole exhibited antagonist properties in animal models of dopaminergic hyperactivity and agonist properties in animal models of dopaminergic hypoactivity. Aripiprazole exhibited high binding affinity _in vitro_ for dopamine D2 and D3, serotonin 5HT1a and 5HT2a receptors and moderate affinity for dopamine D4, serotonin 5HT2c and 5HT7, alpha-1 adrenergic and histamine H1 receptors. Aripiprazole also exhibited moderate binding affinity for the serotonin reuptake site and no appreciable affinity for muscarinic receptors. Interaction with receptors other than dopamine and serotonin subtypes may explain some of the other clinical effects of Aripiprazole. _PHARMACOKINETICS _ Absorption Aripiprazole is well absorbed, with peak plasma concentrations occurring within 3-5 hours after dosing. Aripiprazole undergoes minimal pre-systemic metabolism. The absolute oral bioavailability of the tablet formulation is 87%. There is no effect of a high fat meal on the pharmacokinetics of Aripiprazole. Distribution Aripiprazole is widely distributed throughout the body with an apparent volume of distribution of 4.9 l/kg, indicating extensive extravascular distribution. At therapeutic concentrations, Aripiprazole and dehydro-Aripiprazole are greater than 99% bound to serum proteins, binding primarily to albumin. Biotransformation Aripiprazole is extensively metabolized by the liver primarily by three biotransformation Baca dokumen lengkapnya